
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 23, 2000]
[Document not affected by Public Laws enacted between
  January 23, 2000 and December 4, 2001]
[CITE: 42USC285o-4]

 
                 TITLE 42--THE PUBLIC HEALTH AND WELFARE
 
                    CHAPTER 6A--PUBLIC HEALTH SERVICE
 
              SUBCHAPTER III--NATIONAL RESEARCH INSTITUTES
 
   Part C--Specific Provisions Respecting National Research Institutes
 
              subpart 15--national institute on drug abuse
 
Sec. 285o-4. Medication Development Program


(a) Establishment

    There is established in the Institute a Medication Development 
Program through which the Director of such Institute shall--
        (1) conduct periodic meetings with the Commissioner of Food and 
    Drugs to discuss measures that may facilitate the approval process 
    of drug abuse treatments;
        (2) encourage and promote (through grants, contracts, 
    international collaboration, or otherwise) expanded research 
    programs, investigations, experiments, community trials, and 
    studies, into the development and use of medications to treat drug 
    addiction;
        (3) establish or provide for the establishment of research 
    facilities;
        (4) report on the activities of other relevant agencies relating 
    to the development and use of pharmacotherapeutic treatments for 
    drug addiction;
        (5) collect, analyze, and disseminate data useful in the 
    development and use of pharmacotherapeutic treatments for drug 
    addiction and collect, catalog, analyze, and disseminate through 
    international channels, the results of such research;
        (6) directly or through grants, contracts, or cooperative 
    agreements, support training in the fundamental sciences and 
    clinical disciplines related to the pharmacotherapeutic treatment of 
    drug abuse, including the use of training stipends, fellowships, and 
    awards where appropriate; and
        (7) coordinate the activities conducted under this section with 
    related activities conducted within the National Institute on 
    Alcohol Abuse and Alcoholism, the National Institute of Mental 
    Health, and other appropriate institutes and shall consult with the 
    Directors of such Institutes.

(b) Duties

    In carrying out the activities described in subsection (a) of this 
section, the Director of the Institute--
        (1) shall collect and disseminate through publications and other 
    appropriate means, information pertaining to the research and other 
    activities under this section;
        (2) shall make grants to or enter into contracts and cooperative 
    agreements with individuals and public and private entities to 
    further the goals of the program;
        (3) may, in accordance with section 289e of this title, and in 
    consultation with the National Advisory Council on Drug Abuse, 
    acquire, construct, improve, repair, operate, and maintain 
    pharmacotherapeutic research centers, laboratories, and other 
    necessary facilities and equipment, and such other real or personal 
    property as the Director determines necessary, and may, in 
    consultation with such Advisory Council, make grants for the 
    construction or renovation of facilities to carry out the purposes 
    of this section;
        (4) may accept voluntary and uncompensated services;
        (5) may accept gifts, or donations of services, money, or 
    property, real, personal, or mixed, tangible or intangible; and
        (6) shall take necessary action to ensure that all channels for 
    the dissemination and exchange of scientific knowledge and 
    information are maintained between the Institute and the other 
    scientific, medical, and biomedical disciplines and organizations 
    nationally and internationally.

(c) Report

                           (1) In general

        Not later than December 31, 1992, and each December 31 
    thereafter, the Director of the Institute shall submit to the Office 
    of National Drug Control Policy established under section 1501 \1\ 
    of title 21 a report, in accordance with paragraph (3), that 
    describes the objectives and activities of the program assisted 
    under this section.
---------------------------------------------------------------------------
    \1\ See References in Text note below.
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                 (2) National Drug Control Strategy

        The Director of National Drug Control Policy shall incorporate, 
    by reference or otherwise, each report submitted under this 
    subsection in the National Drug Control Strategy submitted the 
    following February 1 under section 1504 \1\ of title 21.

(d) ``Pharmacotherapeutics'' defined

    For purposes of this section, the term ``pharmacotherapeutics'' 
means medications used to treat the symptoms and disease of drug abuse, 
including medications to--
        (1) block the effects of abused drugs;
        (2) reduce the craving for abused drugs;
        (3) moderate or eliminate withdrawal symptoms;
        (4) block or reverse the toxic effect of abused drugs; or
        (5) prevent relapse in persons who have been detoxified from 
    drugs of abuse.

(e) Authorization of appropriations

    For the purpose of carrying out this section, there are authorized 
to be appropriated $85,000,000 for fiscal year 1993, and $95,000,000 for 
fiscal year 1994.

(July 1, 1944, ch. 373, title IV, Sec. 464P, as added Pub. L. 102-321, 
title I, Sec. 123(b), July 10, 1992, 106 Stat. 362; amended Pub. L. 103-
43, title XX, Sec. 2008(b)(10), June 10, 1993, 107 Stat. 211.)

                       References in Text

    Sections 1501 and 1504 of title 21, referred to in subsec. (c), were 
repealed by Pub. L. 100-690, title I, Sec. 1009, Nov. 18, 1988, 102 
Stat. 4188, as amended.


                               Amendments

    1993--Subsec. (b)(6). Pub. L. 103-43 substituted ``Institute'' for 
``Administration''.


                             Effective Date

    Section effective Oct. 1, 1992, with provision for programs 
providing financial assistance, see section 801(c), (d) of Pub. L. 102-
321, set out as an Effective Date of 1992 Amendment note under section 
236 of this title.


                     Report by Institute on Medicine

    Section 701 of Pub. L. 102-321 directed Secretary of Health and 
Human Services to enter into a contract with a public or nonprofit 
private entity to conduct a study concerning (1) role of the private 
sector in development of anti-addiction medications, including 
legislative proposals designed to encourage private sector development 
of such medications, (2) process by which anti-addiction medications 
receive marketing approval from Food and Drug Administration, including 
an assessment of feasibility of expediting marketing approval process in 
a manner consistent with maintaining safety and effectiveness of such 
medications, (3) with respect to pharmacotherapeutic treatments for drug 
addiction (A) recommendations with respect to a national strategy for 
developing such treatments and improvements in such strategy, (B) state 
of the scientific knowledge concerning such treatments, and (C) 
assessment of progress toward development of safe, effective 
pharmacological treatments for drug addiction, and (4) other related 
information determined appropriate by the authors of the study, and to 
submit to Congress a report of the results of such study not later than 
18 months after July 10, 1992.

                  Section Referred to in Other Sections

    This section is referred to in section 285o of this title.
